Corporate Banner
Satellite Banner
RNAi
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

New Analyses from Phase III ALSYMPCA Trial Presented at ESMO 2012

Published: Monday, October 01, 2012
Last Updated: Monday, October 01, 2012
Bookmark and Share
Radium-223 dichloride (Alpharadin) was significantly superior to placebo in health-related quality of life (QOL) measures.

Algeta ASA has announced that further data and analysis from the phase III ALSYMPCA study of radium-223 dichloride (Alpharadin) in patients with castration-resistant prostate cancer with bone metastases have been presented as two posters at the ESMO 2012 Congress (Vienna, Austria; 28 September - 2 October 2012).

Dr. Gillies O’Bryan-Tear, Algeta’s Chief Medical Officer, said: “These new analyses continue to build our confidence in radium-223 dichloride’s potential for use in the treatment of castration-resistant prostate cancer patients with bone metastases.”

Both posters can be found at www.algeta.com.

Safety of chemotherapy after radium-223 dichloride (Poster 936P)
The first analysis, conducted post-hoc and presented by Dr. Oliver Sartor (Medical Director Tulane Cancer Center, Tulane Medical School, New Orleans, LA, and Principal Investigator for US arm of ALSYMPCA), found that, based on the limited sample size (n=147), hematologic safety profiles for patients receiving chemotherapy after radium-223 dichloride were similar to those for patients receiving chemotherapy after placebo.

The cohort for this analysis consisted of all patients who received chemotherapy after administration of radium-223 dichloride or placebo.

The proportion of patients receiving subsequent chemotherapy was 93/614 (15%) in the radium-223 dichloride group and 54/307 (18%) in the placebo group.

The most common chemotherapeutic agents administered after study drug treatment were docetaxel (n=105), mitoxantrone (n=23), and cyclophosphamide (n=19).

Administering chemotherapy after the study drug had no deleterious effect on patient overall survival (OS).

In the 147 patients from the ALSYMPCA study receiving chemotherapy after study drug, median OS from start of chemotherapy was 15.6 months in the radium-223 dichloride group and 14.6 months in the placebo group (P = 0.663).

Quality of Life assessment (Poster 898PD)
The second, preplanned, analysis, from all 921 patients recruited into ALSYMPCA and presented by Dr. Christopher Parker (Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK, and Principal Investigator for ALSYMPCA), concluded that radium-223 dichloride showed significantly better preservation of quality of life (QOL), with improved functioning and well-being, compared to placebo, as well as confirming previously reported survival and safety endpoints.

Radium-223 dichloride improved the QOL response rate versus placebo (27% vs 18% p < 0.05), and better preserved QOL over time versus placebo (FACT-P: p < 0.05).

QOL was assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EuroQoL (EQ-5D) instruments, both well validated instruments in prostate cancer.

Radium-223 dichloride is not currently approved by the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or any other health authority.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,400+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Algeta Appoints Dr Andreas Menrad as CSO
Dr Menrad will be responsible for developing and executing the Company’s research strategy.
Monday, August 19, 2013
Algeta Celebrates the Opening of Commercial Production Facility for Xofigo®
Official opening of new facility at the Institute for Energy Technology (IFE) in Kjeller, Norway.
Friday, June 21, 2013
Algeta Announces First Sale of Xofigo® in the United States
First sale triggers EUR 50 million milestone payment from Bayer.
Thursday, May 30, 2013
Algeta: FDA Approves Xofigo (radium-223 dichloride)
Xofigo shown in a pivotal phase III trial to significantly improve overall survival.
Friday, May 17, 2013
Algeta’s Partner Bayer Submits Radium-223 for EU Marketing Authorization
Submission to trigger €50 million milestone payment to Algeta.
Monday, April 22, 2013
Algeta Elects New Non-executive Members
Hilde Furberg and Paolo Pucci elected as new members of Algeta’s Board of Directors.
Friday, April 12, 2013
Algeta Initiates New Oncology Research Program to Conjugate Thorium-227 to Epratuzumab
CD22 is a well-validated target for hematological cancers.
Tuesday, January 29, 2013
Updated Phase III Data Confirm Overall Survival Benefit of Alpharadin in Men with CRPC
Submissions seeking marketing approval in US & Europe expected in 2H 2012.
Monday, June 04, 2012
Jeffrey W. Albers Appointed President of Algeta US
Mr. Albers will join Algeta’s executive management team and takes up his position immediately.
Tuesday, January 17, 2012
Algeta Awarded Grant to Develop Targeted Thorium Conjugates
Company has been awarded a NOK 10.5 million grant from the Research Council of Norway.
Tuesday, January 03, 2012
Algeta Appoints Mike Booth as Senior Vice President, Communications and Corporate Affairs
New role created to enhance Algeta's global corporate communications and investor relations activities.
Friday, December 30, 2011
Alpharadin Significantly Improves Overall Survival for CRPC Patients with Bone Metastases
First presentation of full ALSYMPCA phase III data as part of Presidential Session featuring Best and Late-Breaking Abstracts at 2011 EMCC.
Monday, October 10, 2011
Algeta Signs License with Affibody for Tumor-Targeting Molecules
Algeta gains access to two proprietary Affibody® molecules for use in cancer therapy.
Tuesday, August 30, 2011
FDA Grants Fast Track Designation to Alpharadin
Fast Track designation granted to Alpharadin for the treatment of castration-resistant prostate cancer in patients with bone metastases.
Friday, August 26, 2011
Scientific News
Long Telomeres Associated with Increased Lung Cancer Risk
Genetic predisposition for long telomeres predicts increased lung adenocarcinoma risk.
First Artificial Ribosome Designed
Researchers at the University of Illinois at Chicago and Northwestern University have engineered a tethered ribosome that works nearly as well as the authentic cellular component, or organelle, that produces all the proteins and enzymes within the cell.
Identifying a Key Growth Factor in Cell Proliferation
Researchers discover that aspartate is a limiter of cell proliferation.
A Gene-Sequence Swap Using CRISPR to Cure Haemophilia
For the first time chromosomal defects responsible for hemophilia have been corrected in patient-specific iPSCs using CRISPR-Cas9 nucleases
New Tool Uses 'Drug Spillover' to Match Cancer Patients with Treatments
Researchers have developed a new tool that improves the ability to match drugs to disease: the Kinase Addiction Ranker (KAR) predicts what genetics are truly driving the cancer in any population of cells and chooses the best "kinase inhibitor" to silence these dangerous genetic causes of disease.
New Material Opens Possibilities for Super-Long-Acting Pills
A pH-responsive polymer gel could create swallow able devices, including capsules for ultra-long drug delivery.
New Tool For Investigating RNA Gone Awry
A new technology – called “Sticky-flares” – developed by nanomedicine experts at Northwestern University offers the first real-time method to track and observe the dynamics of RNA distribution as it is transported inside living cells.
Access Denied: Leukemia Thwarted by Cutting Off Link to Environmental Support
A new study reveals a protein’s critical – and previously unknown -- role in the development and progression of acute myeloid leukemia (AML), a fast-growing and extremely difficult-to-treat blood cancer.
New Weapon in the Fight Against Blood Cancer
This strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
TOPLESS Plants Provide Clues to Human Molecular Interactions
Scientists at Van Andel Research Institute have revealed an important molecular mechanism in plants that has significant similarities to certain signaling mechanisms in humans, which are closely linked to early embryonic development and to diseases such as cancer.
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!